The FDA today announced that it has updated labeling of the antidepressant citalopram hydrobromide to prevent development of an abnormal heart rhythm.
In August, the FDA issued a drug safety communication stating that dosing of citalopram (Celexa, Forest) should not exceed 40 mg per day because it could potentially cause dangerous abnormalities in the heart’s electrical activity, particularly QT prolongation, which can lead to an abnormal heart rhythm called torsade de pointes.
The revised labeling includes:
- Recognition that citalopram use should be avoided if possible in certain patients, including those with underlying heart conditions and those predisposed to having low levels of potassium and magnesium in the blood. In patients for whom citalopram is necessary, electrocardiogram and/or electrolyte monitoring should be performed.
- Patients with congenital long QT syndrome are at particular risk for torsade de pointes, ventricular tachycardia and sudden death when given drugs that prolong the QT interval. Nevertheless, the labeling recommendation for patients with congenital long QT syndrome has been changed from “contraindicated” to “not recommended” because the FDA recognizes that some patients with this condition may lack viable alternatives or may benefit from a low dose of citalopram.
- The maximum recommended dose of citalopram is 20 mg per day for patients aged older than 60 years.
- Citalopram should be discontinued in patients who are found to have persistent QTc measurements of more than 500 ms.